To overcome disadvantages of the prior methods of valve reconstruction, Cardiomend LLC (the assignee of the present application), has developed improved, more easily reproducible, less complicated, and generally standardized, methods and devices for reconstructing heart valves. These methods and devices are generally described in Love U.S. Pat. No. 5,716,399, Love U.S. Pat. No. 6,129,758, Love et al U.S. Pat. No. 6,328,763, Love U.S. Pat. No. 6,425,902, Love et al. U.S. Pat. No. 6,598,307, and Love et al. U.S. Pat. No. 6,678,962 (the “Love Patents”), each of which is incorporated herein by reference in its entirety. The Love Patents generally describe innovative methods and devices for reconstructing semilunar valves (aortic and pulmonic) using a novel unitary trefoil tissue pattern, which is preferably made of lightly tanned autologous pericardium. The methods described in the Love Patents generally include the steps of (a) removing the diseased native valve leaflets, (b) sizing of the heart valve based on the distance between adjacent commissures of the native valve annulus, (c) cutting a trefoil tissue pattern corresponding in size to the native valve annulus, (d) temporarily mounting the tissue pattern on a surgical instrument for holding the tissue in a configuration of a circulatory system valve to facilitate attachment of the tissue, and (e) suturing the tissue to the native valve annulus.
Prior art FIG. 1 illustrates an embodiment of a trefoil tissue pattern for use with the methods and devices disclosed in the Love Patents. The tissue pattern is more fully described and shown in Love et al. U.S. Pat. No. 6,425,902. The trefoil pattern is used to form a tri-leaflet valve structure. An embodiment of the trefoil valve tissue pattern 25 has three lobes, 16a, 16b and 16c, arranged about a center orifice 19. Each of lobes 16a, 16b and 16c of the trefoil valve tissue pattern, when oriented in the configuration of a valve and affixed to the native valve annulus, will form one leaflet or lobe of the valve structure. The tissue pattern is preferably cut in a predetermined size that corresponds to the size of the native valve annulus.
The present invention relates to a device for cutting a tissue pattern for use with the methods described in the Love Patents and, in particular, for use in connection with the stent and method for repairing or replacing a circulatory system valve as described in co-pending, commonly assigned U.S. patent application Ser. No. 10/898,703, entitled Stent and Method for Circulatory System Valve Repair or Replacement, filed concurrently herewith and incorporated herein by reference in its entirety. Among the advantages of the present invention is that it provides a mechanism for quickly and easily cutting a precise tissue pattern without dragging the material and possibly tearing the tissue or distorting the geometry of the tissue pattern, as would often occur using a straight scalpel blade. The cutting device can also quickly attach a stent to the valve repair material. Furthermore, the cutting device cannot readily be re-used so as to avoid the risk of contamination, infection, and ineffective cutting resulting from the re-use of the cutting blade.